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Dear Doctor Letter (Rote-Hand-Brief) on Procoralan® (ivabradine): New contraindication and recommendations for minimisation of risks of cardiovascular events and severe bradycardias PDF, 1MB, File is accessible Date: 11. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ivabradine

The company Servier Deutschland GmbH is circulating information that concomitant use of ivabradine with verapamil or diltiazem is now contraindicated.

Dear Doctor Letter (Rote-Hand-Brief) on Tecfidera® (dimethyl fumarate): Suspected case of progressive multifocal leukoencephalopathy (PML) PDF, 195KB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethyl fumarate

The company Biogen Idec GmbH is circulating information on a fatal case of progressive multifocal leukoencephalopathy (PML) in a patient with a severe and long-term lymphopenia treated with Tecfidera®.

Dear Doctor Letter (Rote-Hand-Brief) on medicinal products containing bromocriptine: Restrictions of indication regarding inhibition of lactation PDF, 1MB, File is accessible Date: 04. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: bromocriptine

The marketing authorisation holders of medicinal products containing bromocriptine are circulating information that bromocriptine should only be taken in strengths up to 2.5 mg per individual dose for prevention or inhibition of lactation …

Information on medicinal products affecting the renin-angiotensin system: Key elements for communication PDF, 42KB, File is accessible Date: 01. December 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: ACE-Hemmer, Angiotensin-II-Rezeptor-Antagonisten, Aliskiren

The Pharmacovigilance Risk Assessment Committee (PRAC) has adopted key elements regarding communication of the outcome of the safety review regarding medicinal products that affect the renin-angiotensin system.

Information Letter on Eligard® (leuprorelin acetate depot injection): Risk of lack of efficacy due to incorrect reconstitution and administration PDF, 521KB, File is accessible Date: 28. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: leuprorelin acetate

The company Astellas Pharma GmbH is circulating information on a possible lack of clinical efficacy that may occur if the product is reconstituted incorrectly.

Dear Doctor Letter (Rote-Hand-Brief) on Fenistil® 1 mg/ml solution for injection (dimethindene maleate): Quality defects; recall of two batches PDF, 483KB, File is accessible Date: 25. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: dimethindene maleate

The company Novartis Consumer Health GmbH is sending out information on the recall of batches 11027154 and 11045012 of the medicinal product Fenistil® 1 mg/ml solution for injection as the vials of both batches partially exhibit leakage at the …

Information letter on medicinal products containing codeine as liquid dosage forms by UCB Pharma GmbH: Recall Date: 13. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: codein

The company UCB Pharma GmbH is circulating information on the recall of medicinal products containing codeine as liquid dosage forms.

Information letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product and special temporary preparation instructions. PDF, 75KB, File is accessible Date: 07. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Information Letter on Xofigo® (radium 223 dichloride): Temporary shortage of the medicinal product PDF, 2MB, File is accessible Date: 05. November 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: radium-223-dichlorid

The company Bayer Vital GmbH is circulating information on a worldwide temporary shortage of the medicinal product Xofigo® as recently produced batches did not pass routine quality checks prior to release.

Dear Doctor Letter (Rote-Hand-Brief) on Beofenac® (aceclofenac): New contraindications and warnings PDF, 1MB, File is accessible Date: 28. October 2014 Topics: Pharmakovigilanz Type: Direct Healthcare Professional Communication

Active substance: aceclofenac

The company Almirall Hermal GmbH is circulating information that treatment with aceclofenac - similar to that with diclofenac and selective COX-2 inhibitors - is associated with an increased risk of arterial thrombotic events.